1. Field of the Invention
The present invention relates to methods, compositions and systems for the prevention and treatment of diaper rash.
2. Discussion of Related Art
Diaper rash (also referred to as diaper dermatitis or incontinent dermatitis) is a common form of irritation and inflammation affecting both infants and incontinent adults, typically in those areas normally covered by a diaper or in areas immediately adjacent to the diaper area. It is generally accepted that diaper rash is a condition that is, in its most simple stages, a contact irritant dermatitis. The irritation of simple diaper rash results from extended contact of the skin with urine, or feces, or both. Diapers are worn to catch and hold the body waste, but generally hold the waste in direct contact with the skin until changed, sometimes for extended periods of time. The same is true for an incontinence pad, or incontinence brief.
While it is known that body waste causes diaper rash, identification of the precise component or components of the urine and/or feces which are responsible for the resulting irritation of the skin remains the subject of much controversy. The most commonly accepted list of factors linked to diaper rash includes ammonia, bacteria, the products of bacteria action, urine pH, Candida albicans, and moisture.
Encompassed by the term xe2x80x9cdiaper rashxe2x80x9d are a wide variety of related conditions including, for example, friction rash, irritant rash, allergic rash, intertrigo, seborrhea rash and psoriasis. Friction rash is the most common form of diaper rash, and affects almost all infants at some time. It is most common on areas where friction is most pronounced, such as the inner thighs, or under the elastic of diapers that are too tight. It comes and goes quickly, and responds well to frequent diaper changes, airing out, and protective barriers. Irritant rash is usually most conspicuous on the exposed areas, such as the round part of the buttocks. It tends to spare skin folds and creases, and is generally the result of contact with stool enzymes or irritants such as harsh soaps, baby wipes, detergents or topical medicines. Allergic rash may occur in combination with an irritant rash or by itself. It is also more common on exposed areas, and the rash resembles poison oak. Intertrigo is caused by moist heat, such as that commonly occurs deep in skin folds. The involved skin looks thin, as if it has lost several layers. Seborrhea rash is a salmon-colored, greasy rash with yellowish scales, and is also typically worse in skin folds. Psoriasis is a stubborn rash that does not necessarily look distinctive. Other signs of psoriasis usually accompany the diaper rash, though, such as pitting of the nails or dark red areas with sharp borders and fine silvery scales on the trunk, face, or scalp. In addition to its common appearance in the diaper area, the term diaper rash is also intended to refer to skin irritations at other areas of the human body that may be caused by prolonged exposure to, for example, moisture, heat, irritants, enzymes and/or pressure.
Skin wetness appears to be the common denominator underlying the various causes of diaper rash. Urinary wetness increases skin friction, raises the skin pH, makes the skin less cohesive, and makes it more permeable. These effects combine to intensify the action of stool enzymes or other irritants that then inflame the skin. Even skin lesions of systemic illnesses tend to concentrate in areas where the skin is already damaged. In a typical diaper rash, with the protective layer of the outermost layer of skin (the stratum corneum) damaged, microorganisms such as yeast or bacteria can more readily invade the inflamed skin.
Because the suspected agents of diaper rash, discussed above, all possess diverse properties and require varied therapies, conventional methods of treatment for diaper dermatitis have been directed toward a straightforward attempt to minimize the contact of the skin with the feces or urine present in a soiled diaper. An artificial barrier is usually provided between the skin and the body waste to accomplish this. There have also been attempts directed toward counteracting other suspected causes of diaper rash by promoting dryness in the diapered area, and preventing microbial growth and inflammation with conventional agents. Such a strategy would include frequent diaper changing, reduced use of plastic pants, triple diapering, careful washing and sterilization of diapers, treatment with an anti-Candidal agent, reduction of inflammation (by topical application of a low potency glucocorticoid steroid), and the possible use of a bacteriostatic agent as a prophylactic measure in the perineal rinse. However, because the exact components of urine or feces which act as factors or cofactors contributing to diaper dermatitis have never been precisely identified, the most effective method of treating diaper rash to date has been the artificial barrier. This has led to the frequent use of an occlusive, barrier-type topical, such as petrolatum or zinc oxide, to provide protection, preventing the unknown offending component from coming in contact with the skin.
Presently, there are a wide variety of ointments, creams or lotions known and available in the market for the treatment of diaper rash. Most of these products include ingredients that offer some beneficial property to the product, for example, by acting as a water repellant, emollient, neutralizer or antibiotic. Examples of ingredients that are commonly included in such ointments are mineral oil, silicone fluids (e.g. dimethicone and cyclomethicone), petrolatum, cod liver oil, lanolin, zinc oxide, talc, calamine, kaolin, topical starch and allantoin. For example, Desitin(copyright) ointment (Pfizer, Inc.) is probably the most common topical used in treating diaper rash. It contains common barrier materials (zinc oxide and petrolatum) and additionally contains two common skin conditioning agents (cod liver oil and lanolin).
Examples of patents that describe various diaper rash treatment compositions include the following: U.S. Pat. No. 5,110,593 to Benford, U.S. Pat. No. 5,300,286 to Gee, U.S. Pat. No. 5,436,007 to Hartung et al., U.S. Pat. No. 5,744,469 to Tran, U.S. Pat. No. 4,857,321 to Thomas, U.S. Pat. No. 5,229,105 to Wilmsmann, U.S. Pat. No. 5,091,193 to Enjolras et al., U.S. Pat. No. 5,869,071 to Wieselman et al., U.S. Pat. No. 5,194,261 to Pichierri, U.S. Pat. No. 5,362,488 to Sibley et al. and U.S. Pat. No. 5,762,945 to Ashley et al. These, and all other references cited herein are hereby incorporated by reference herein in their entireties.
Many recent developments in the field of diaper rash treatment have focused on new ingredients that offer either antibiotic performance or act as a superior moisture barrier. For example, there are a number of pharmaceutical actives that can be used, but these are not available in over-the-counter products. Additionally, there have been proposed lotions having reactive polymeric components that form a plastic coating on the surface of the skin. Examples of such developments include U.S. Pat. No. 5,879,688 to Coury et al., U.S. Pat. No. 5,874,479 to Martin, U.S. Pat. No. 5,762,945 to Ashley, U.S. Pat. No. 5,728,391 to Ikeya et al., U.S. Pat. No. 5,721,306 to Tsipursky et al., U.S. Pat. No. 5,674,912 to Martin, U.S. Pat. No. 5,658,956 to Martin et al., and U.S. Pat. No. 5,618,529 to Pichierri.
A major drawback of most products currently available for the treatment of diaper rash, however, is that they are very viscous and messy to administer to the skin. Such products require that the person applying the product spread the product by rubbing the same into or over the skin. While this requirement is typically acceptable in the case of a parent applying the product to the skin of an infant child, it is a drawback where a caregiver is in charge of providing such a treatment to multiple persons, especially multiple incontinent adults. The application of the product is messy and awkward because the product is difficult to wash off of ones hand due to its oily, hydrophobic nature. Additionally, the caregiver must first use one set of gloves to clean the patient, and then use another set of gloves to apply the ointment or lotion. This results in wasted time and resources.
Other new products address the difficulty and mess associated with applying viscous ointments and lotions by providing systems that have pads or other applicators that can be used to smear the ointment onto the skin. A representative example of such a system is set forth in U.S. Pat. No. 4,893,956 to Wojcik et al. A disadvantage of such applicators, however, is that they may become contaminated upon use and should therefore be discarded after a single use.
The above shortcomings of the prior art are addressed by the present invention, which provides methods, compositions and systems for administering diaper rash compositions to a selected skin treatment area without the mess, inconvenience and inefficiency experienced in the prior art.
The present invention addresses a number of problems associated with currently-known diaper rash treatments by providing methods, compositions and systems for diaper rash treatment involving application of a treatment composition as an atomized spray. Provided by the invention are systems for applying a variety of diaper rash treatment compositions to a selected treatment area without the need for the person administering the treatment to directly contact the composition or the skin of the patient.
In one aspect of the invention, there is provided a method for treating diaper rash, the method comprising (1) providing a diaper rash treatment system comprising an atomizing spray dispenser and a diaper rash treatment composition; wherein the composition has a viscosity of from about 1 to about 1000 centipoise; wherein the dispenser comprises a container and an atomizing spray delivery mechanism affixed to the container; and wherein the composition is positioned in the container, (2) selecting a skin treatment area featuring incontinent dermatitis or substantially at risk of developing incontinent dermatitis; and (3) passing the composition through the mechanism to atomize the composition and to propel the atomized composition toward the skin treatment area; wherein the composition comprises at least about 1 percent solid particulate material by weight and at least about 20 percent by weight of a fluid base material. The solid material is preferably particulate zinc oxide.
In another aspect of the invention, there is provided a method for treating diaper rash, the method comprising (1) providing a diaper rash treatment system comprising an atomizing spray dispenser and a diaper rash treatment composition; wherein the composition has a viscosity of from about 1 to about 1000 centipoise; wherein the dispenser comprises a container and an atomizing spray delivery mechanism affixed to the container; and wherein the composition is positioned in the container; (2) selecting a skin treatment area featuring incontinent dermatitis or substantially at risk of developing incontinent dermatitis; and (3) passing the composition through the mechanism to atomize the composition and to propel the atomized composition toward the skin treatment area; wherein the composition comprises lanolin, petrolatum, cod liver oil and a fluid base material.
In another aspect of the invention, there is provided a method for treating diaper rash, the method comprising (1) providing a diaper rash treatment system comprising an atomizing spray dispenser and a diaper rash treatment composition; wherein the composition has a viscosity of from about 1 to about 1000 centipoise; wherein the dispenser comprises a container and an atomizing spray delivery mechanism affixed to the container; and wherein the composition is positioned in the container; (2) selecting a skin treatment area featuring incontinent dermatitis or substantially at risk of developing incontinent dermatitis; and (3) passing the composition through the mechanism to atomize the composition and to propel the atomized composition toward the skin treatment area; wherein the composition comprises a member selected from the group consisting of calendula, chamomile and comfrey.
The invention provides in another aspect a system for treating diaper rash, the system comprising (1) a diaper rash treatment composition having a viscosity of from about 1 to about 1000 centipoise, wherein the composition comprises at least about 1 percent particulate zinc oxide by weight and at least about 20 percent by weight of a fluid base material; and (2) an atomizing spray dispenser for delivering the composition to a skin treatment area; wherein the dispenser comprises a container and an atomizing spray delivery mechanism affixed to the container; and wherein the composition is positioned in the container.
The invention provides in another aspect a system for treating diaper rash, the system comprising (1) a diaper rash treatment composition having a viscosity of from about 1 to about 1000 centipoise, wherein the composition comprises lanolin, petrolatum, cod liver oil and a fluid base material; and (2) an atomizing spray dispenser for delivering the composition to a skin treatment area; wherein the dispenser comprises a container and an atomizing spray delivery mechanism affixed to the container; and wherein the composition is positioned in the container.
The invention provides in another aspect a system for treating diaper rash, the system comprising (1) a diaper rash treatment composition having a viscosity of from about 1 to about 1000 centipoise, wherein the composition comprises a member selected from the group consisting of calendula, chamomile and comfrey and a fluid base material; and (2) an atomizing spray dispenser for delivering the composition to a skin treatment area; wherein the dispenser comprises a container and an atomizing spray delivery mechanism affixed to the container; and wherein the composition is positioned in the container.
In another aspect of the invention, there is provided a method for treating diaper rash, comprising (1) selecting a substantially clean skin treatment area afflicted by incontinent dermatitis or substantially at risk of developing incontinent dermatitis; and (2) propelling toward the skin treatment area an atomized spray comprising a diaper rash treatment composition having a viscosity of from about 1 to about 1000 centipoise.
It is an object of the invention to provide novel methods, compositions and systems for preventing or treating diaper rash.
It is another object of the invention to provide novel methods, compositions and systems for preventing or treating diaper rash whereby a treatment composition may be administered to a skin surface without the need for the person administering the composition to come into contact with the composition or the skin of the patient.
An additional object of the invention is to provide novel methods, compositions and systems for preventing or treating diaper rash whereby a treatment composition may be administered to a skin surface by atomizing the composition and propelling the atomized composition toward the skin surface.
Further objects, advantages and features of the present invention will be apparent from the detailed description herein.